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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03750903
Other study ID # E2619-R
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 4, 2019
Est. completion date September 30, 2024

Study information

Verified date October 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the current proposal is to identify 1) how aging-related changes in GABAergic cortical inhibition affect motor performance, and 2) how aerobic exercise may improve inhibitory function and facilitate motor learning.


Description:

The current proposal seeks quantify neural inhibition using magnetic resonance spectroscopy (MRS) and transcranial magnetic stimulation (TMS) in older Veterans to identify how each measures contributes to aging-related changes in motor performance. Currently, over 56% (11.8 million) of Veterans are over age 60. Recent research has shown that aging is associated with decreased cortical inhibition and impaired hand motor function. However, this loss of inhibition is not an inescapable consequence of aging. The investigators' previous work that healthy older adults who engage in regular physical activity show increased cortical inhibition and improved dexterity as compared to their sedentary age cohort. This indicates that aerobic training may reverse aging related changes in cortical inhibition and alteration of tonic levels of cortical excitability can have a powerful impact on motor performance in the aging brain. In the current proposal, the investigators will enroll older adults to assess how different measurements (TMS and MRS) of the dominant inhibitory neurotransmitter in the brain - GABA differ in relation to motor control. During the MRS scan, participants will perform a motor learning task to assess change in GABA level throughout the acquisition session. These data will be compared with measures of cortical inhibition using TMS to quantify neurotransmitter receptor activity with respect to aging-related changes in motor performance. The investigators will also be comparing the effects of an aerobic exercise intervention as compared to a contact matched stretching control. The investigators believe this project is the first inquiry of its kind and will have an important impact in the understanding of aging-related neurophysiological changes in the brain and how it can remediate associated behavioral declines.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date September 30, 2024
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - living persons aged 50-85 Exclusion Criteria: - unmanaged diabetes - participants completing vigorous exercise per week - participants whose profession requires vigorous physical labor - contraindication to magnetic resonance imaging

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Aerobic Exercise
Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.
Stretching and Balance Training
Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.

Locations

Country Name City State
United States Atlanta VA Medical and Rehab Center, Decatur, GA Decatur Washington

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Magnetic Resonance Spectroscopy Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning. Pre/Post 12 week intervention
Secondary Transcranial Magnetic Stimulation Measure changes in TMS measures of cortical excitability pre/post intervention. Pre/Post 12 week intervention
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